International Regulatory Affairs （Senior Manager/Associate Director）
想定年収
1,400万円 ~ 1,650万円
勤務地
東京都
仕事内容
This position is part of the International Regulatory Affairs team and is based in Tokyo. The role is responsible for developing regulatory strategies, preparing and executing submissions for marketing applications and post-marketing maintenance, and serving as the primary liaison with Japanese regulatory authorities (PMDA, MHLW). It also involves supporting clinical development in Japan, aligning with global teams, and monitoring regulatory changes that may impact company products.
募集人数
1人
応募条件
技能/経験
EDUCATION
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
A bachelor of science degree in life science.
Qualified Pharmacist is a plus.
Fluent in Japanese and English.
EXPERIENCE
Minimum of ten years of industry experience with at least six years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including good knowledge and understanding of the Japanese regulatory environment.
Proven track record for preparing, submitting, and gaining approvals for JNDAs.
The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
学歴
大学
職務経験
要 (3年以上)
業界経験
要
年齢
年齢制限不問
英語力
その他語学力
語学力詳細
ビジネスレベルの英語力
勤務条件
雇用形態
無期雇用
試用期間
有り(3ヶ月)
給与
年俸制
年収：1,400万円 ~ 1,650万円
月額基本給：100万円～120万円
現職のご年収と経験を踏まえて決定いたします。
賞与・インセンティブ
年1回
※別途ボーナス／RSU付与予定あり
（オファー時に詳細をご確認ください）
（詳細はポジション、ご経験により異なります）
昇給
有り 年1回
subject to review and adjustment by the Company for every one-year period commencing from the Employment Date
※However, there is no guarantee that the salary will be increased or maintained.
勤務地
東京都
就業時間
09:00～17:30
休憩時間：60分
残業：月10時間～40時間程度
管理監督職
The Employee's working hours shall be in accordance with the Flexible Working Hour System.
The core working hours shall be 11:00 AM to 3:00 PM. The Employee shall take a one (1) hour break during the core working hours.
The Flexible Working Hours shall be as follows:
Start time: Any time between 7:00 AM and 11:00 AM
Finish time: Any time between 3:00 PM and 10:00 PM
残業手当
管理監督職のため、労働基準法４１条により、労働時間、休憩、休日の割増賃金の規定は適用されません。
※詳細はオファー時にご確認ください
通勤手当
交通費：全額支給(社内規定に基づく)
休日・休暇
完全週休二日制, 土, 日, 祝日, 年末年始
年間有給休暇：有給休暇：入社6ヶ月経過後に12日付与
【休日・休暇詳細】
夏季休暇あり（3日）
社会保険
雇用保険, 健康保険, 労災保険, 厚生年金
求人No.：NJB2323580
最終更新日：2025/8/21